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ozenoxacin

Last Updated: September 12, 2018
Result type: Reports
Project Number: SR0553-000
Product Line: Common Drug Review

Generic Name: ozenoxacin

Brand Name: Ozanex

Manufacturer: Ferrer Internacional, S.A.

Indications: Impetigo

Manufacturer Requested Reimbursement Criteria1: For the topical treatment of impetigo in patients aged 2 months and older.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedDecember 14, 2017
Patient group input closedFebruary 09, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsFebruary 13, 2018
Patient group comments on input summary closedFebruary 21, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJanuary 25, 2018
Submission accepted for reviewFebruary 08, 2018
Review initiatedFebruary 13, 2018
Draft CDR review report(s) sent to applicantApril 30, 2018
Comments from applicant on draft CDR review report(s) receivedMay 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedMay 16, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJune 08, 2018
Canadian Drug Expert Committee (CDEC) meetingJune 20, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 05, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedAugust 17, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaOctober 17, 2018
CDEC Final Recommendation issued to applicant and drug plansOctober 24, 2018
CDEC Final Recommendation posted-
Final CDR review report(s) and patient input posted-

Tags

dermatology, pediatrics, impetigo, Ozanex; ozenoxacin; Xepi; impetigo; Pediatric; Paediatric; Child